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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

A report released by the Ombudsman's Office of the US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) for 2011 says smaller companies are contacting it more because they are confused about which regulations apply to them and have more to lose from an adverse decision than do larger companies.

Most of the commercial companies contacting the CDER Ombudsman, which mediates disagreements between the agency and outside entities, were "smaller, emerging biotechnology and pharmaceutical companies," explained the Ombudsman's office.

The office noted it often receives pleas for assistance from smaller companies, who may be unfamiliar with regulations or grappling with how regulations apply to their specific products. The novelty of many smaller companies' products is a contributing factor in this, said the Ombudsman.

"Smaller companies often develop novel drug and biotechnology products that have no established regulatory path," wrote the Ombudsman. "Though welcome, this can be a challenge both for CDER and companies during development and review."

The report also details the stark choice many companies feel when preparing to disagree with a CDER decision.

"Though a disagreement between a company and CDER is not desirable for any company, small companies postulated (to the Ombudsman) that the short-term financial fitness of a small company might be more at risk," explained the Ombudsman. "Therefore, any rapid means of resolving a dispute, including contacting the CDER Ombudsman, is a preferred option."